Events

Recall of Device Recall Fildes Enrichment

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Co..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61305
  • Event Risk Class
    Class 2
  • Event Number
    Z-1282-2012
  • Event Initiated Date
    2012-02-20
  • Event Date Posted
    2012-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107775
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Culture media, general nutrient broth - Product Code JSC
  • Reason
    In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended.
  • Action
    Becton Dickinson (BD) sent an "URGENT PRODUCT RECALL" letter dated February 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard any remaining affected product. BD will issue replacements for the discarded product. Additionally, an Acknowledgment Form was attached for customers to complete and return to the firm via fax to 410-316-4258. Contact BD Technical Services Department for questions regarding this notice.

Device

Device Recall Fildes Enrichment
  • Model / Serial
    Lot 1186346, exp June 22, 2012 Lot 1229762, exp August 03, 2012
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Japan, Mexico, and Taiwan.
  • Product Description
    Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic Systems, 250 Schilling Circle, Cockeysville, MD 21030. || Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA